Table 5.
First Generation INSTIs: Selected drug-related adverse events after week 48 recorded in 2% or more patients in either treatment group
| Raltegravir(RAL + FTC/TDF) | Elvitegravir(EVG/COBI/FTC/TDF) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| STARTMRKa | ONCEMRKa | GS-236-0102b | GS-236-0103b | GS-292–0104/0111d | ||||||
| Adverse Reaction | RAL n = 281 | EFV n = 282 | RAL 1200 mg QD n = 531 | RAL 400 mg BID n = 266 | EVG/ COBI FTC/ TDF n = 348 | EFV/ FTC/ TDF n = 352 | EVG/ COBI/ FTC/ TDF n = 353 | ATV/ RTV + FTC/ TDF n = 355 | EVG/ COBI/ FTC/ TAF N = 866 | EVG/ COBI/ FTC/ TDF N = 867 |
| Diarrhea | 1% | 3% | 2% | 3% | 23% | 19% | 22% | 27% | 17% | 19% |
| Nausea | 3% | 4% | 7% | 7% | 21% | 14% | 20% | 19% | 15% | 17% |
| Vomiting | - | - | 2% | 1% | - | - | - | - | 7% | 6% |
| Fatigue | 1% | 3% | - | - | 11% | 13% | 14% | 13% | 8% | 8% |
| Upper respiratory infection | - | - | - | - | 14% | 11% | 15% | 16% | 11% | 13% |
| Dizziness | 1% | 6% | 2% | 3% | 7% | 24% | - | - | 5% | 4% |
| Headache | 4% | 5% | 3% | 5% | 14% | 10% | 15% | 12% | 14% | 13% |
| Insomnia | 4% | 3% | - | - | 9% | 14% | - | - | 7% | 6% |
| Depression | - | - | - | - | 9% | 11% | - | - | - | - |
| Rash | - | - | - | - | 6% | 12% | - | - | 6% | 5% |
| Discontinuations due to drug-related clinical adverse events | 1% | 4% | 0% | 1% | 4%c | 5%c | 4%c | 5%c | 1% | 1% |
| References | [90] | [63] | [91] | [11] | [65] | |||||
Dash (-) indicates that information regarding this adverse effect was not reported in the study results
ATV atazanavir, COBI cobicistat, EFV efavirenz, EVG elvitegravir, FTC emtricitabine, RAL raltegravir, RTV ritonavir, TDF tenofovir disoproxil fumarate
aReported as drug-related clinical adverse events of moderate-severe intensity
bReported as adverse events in ≥ 10% of patients in either group
cDiscontinuations reported as patients with any treatment-emergent adverse event leading to premature discontinuation of study drug; whether they were deemed to be drug-related was not distinguished
dReported as adverse events in ≥ 5% of patients in either group